The objective of this study is to evaluate the efficacy and safety of the Glofitamab bridging ASCT regimen in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and to provide better clinical benefits to these patients.
This study seeks to include patients aged 18 to 70 years with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have undergone at least a second-line systemic treatment, excluding those with prior resistance to Glofitamab. Based on their disease status following the second-line treatment, participants will be categorized into three groups: A, B, and C. Group A will consist of patients who exhibit partial response (PR) or are circulating tumor DNA (ctDNA) positive after second-line treatment and are planning to undergo autologous stem cell transplantation (ASCT) or Glofitamab as a bridging therapy to ASCT. Group B will include patients who achieve complete response (CR) and are ctDNA negative post-second-line treatment, and they will receive ASCT as consolidation therapy. Patients in Group B who achieved CR and were ctDNA negative following second-line treatment will proceed directly to ASCT consolidation therapy. In Group C, patients who exhibited stable disease (SD) or progressive disease (PD) after second-line treatment were reassessed following two cycles of Glofitamab. Those who attained PR subsequently underwent ASCT consolidation therapy, whereas patients achieving CR had the option to either undergo ASCT or continue with Glofitamab maintenance therapy. Patients with SD or PD were excluded from the study. Patients exhibiting SD or PD were excluded from the cohort. Individuals who have successfully undergone autologous transplantation and subsequent maintenance therapy with Glofitamab will be monitored for assessments of efficacy and survival outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
1. Immunotargeted therapy * Ottuzumab introvenous infusion, 1000mg day1; * Glofitamab introvenous infusion Group A: 2.5mg day8 2. Autologous stem cell transplantation SEAM regimen * Simustine 250mg/m2 orally, day1 * Etoposide 200mg/m2 intravenous infusion, day2-5 * Cytarabine 400mg/m2 intravenous infusion, day2-5 * Metformin 140mg/m2 intravenous infusion, day6; Patients in Group A who intend to receive Glofitamab+ASCT will receive Glofitamab 2.5mg on day8 and start ASCT pretreatment on day15.
Group B patients initiated ASCT treatment directly after evaluating the efficacy of salvage treatment
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGComplete remission rate(CRR)
The rate of patients who achieved CR after treatment with Glofitamab bridging ASCT Regimen
Time frame: At the end of 3 months after ASCT
Main adverse reactions
The safety and tolerability of the therapeutic regimen measured by the major adverse events.
Time frame: Start from the first day of Immunotargeted therapy to 1 month after treatment with Glofitamab bridging ASCT Regimen
Overall response rate(ORR)
The rate of patients who achieved CR or PR after treatment with Glofitamab bridging ASCT Regimen
Time frame: At the end of 3 months after ASCT.
2-year progression-free survival(PFS)
PFS will be assessed from the first day of Immunotargeted therapy to date of progression, relapse, death or end of follow-up.
Time frame: From enrollment to 2 year after the treatment of last patient
2-year overall survival(OS)
OS will be assessed from the first day of Immunotargeted therapy to date of death or end of follow-up.
Time frame: From enrollment to 2 year after the treatment of last patient
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1. Immunotargeted therapy * Ottuzumab introvenous infusion, 1000mg day1; * Glofitamab introvenous infusion Group C: cycle1 2.5mg day8, 10mg day15 cycle2 30mg day21 2. Autologous stem cell transplantation SEAM regimen * Simustine 250mg/m2 orally, day1 * Etoposide 200mg/m2 intravenous infusion, day2-5 * Cytarabine 400mg/m2 intravenous infusion, day2-5 * Metformin 140mg/m2 intravenous infusion, day6; After two treatment cycles with Glofitamab, patients in group C had a PET-CT to assess efficacy. Those with partial remission proceeded to ASCT consolidation, those with complete remission chose between ASCT or Glofitamab maintenance, and those with stable disease or progressive disease exited the trial.